Bioporto A/s · OMXCOP:BIOPOR

Bioporto A/s — Q3 2021 Earnings Presentation

21 slides from Bioporto A/s's earnings presentation, Nov 17, 2021

  1. Slide 1: Interim Report, Q3 2021

    Interim Report, Q3 2021 BioPorto November 17, 2021 © Copyright BioPorto 1

  2. Slide 2: Forward-Looking Statements

    Forward-Looking Statements References herein to this presentation shall mean and include this document, any oral presentation accompanying this document provided by BioPorto A/S (the “Company”) and any further information that may be made available in connection with the subject matter contained her

  3. Slide 3: Agenda

    Agenda 1 Highlights from Q3 2021 2 Q1-Q3 2021 financial results 3 Organizational update 4 Regulatory update 5 2021 guidance © Copyright BioPorto 3

  4. Slide 4: Highlights from Q3 2021

    Highlights from Q3 2021 • Revenue growth of 13% in USD on RUO sales of The NGAL Test and new orders on ELISA Kits • Tony Pare appointed new CEO and Neil Goldman appointed CFO • Enrollment in US clinical trial of The NGAL Test continues, but at slow pace. Expected to be finalized during 1H 2022. • Te

  5. Slide 5: Q1-Q3 2021 financial results

    Q1-Q3 2021 financial results © Copyright BioPorto 5

  6. Slide 6: Growth of 13% (USD) driven by increase in RUO sales

    Growth of 13% (USD) driven by increase in RUO sales of The NGAL Test and ELISA kits in Q3 2021 Revenue by Product Category (DKKm) US NGAL 2,7 ROW 2,6 ROW Q3 2020 Q3 2021 +17% Increase in revenue (DKK) from 1,7 RUO sales of The NGAL Test in US 1,7 from Q3 2020 to Q3 2021 ELISA Kits +217% 1,0 US US 0,

  7. Slide 7: Revenue growth of 19% in USD (11% in DKK) in Q1-Q3 2021

    Revenue growth of 19% in USD (11% in DKK) in Q1-Q3 2021 Revenue by Quarter (DKKm) NGAL Product Sales by Quarter (LTM, DKKm) NGAL 2020 2021 5,6 6,7 6,6 7,6 +68% 14 14 13 13 12 12 5,3 4,7 11 4,2 10 10 9 10 9 8 7 6 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2018 2018 2018 2018 2019 2019 2019 2019 202

  8. Slide 8: Enrollment postponements and focus on cost reduce EBIT loss and provide funding to Q3 2022

    Enrollment postponements and focus on cost reduce EBIT loss and provide funding to Q3 2022 EBIT and cash position (DKKm) Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021 Q3 2021 • EBIT loss reduced DKK 3.2 million in Q3 107,9 2021 compared to last year due to top EBIT 87,0 line growth and lower R&D costs Cas

  9. Slide 9: Organizational update

    Organizational update © Copyright BioPorto 9

  10. Slide 10: New highly experienced international management team in place

    New highly experienced international management team in place Tony Pare Neil Goldman CEO CFO AS OF NOV. 20, 2021 AS OF NOV. 15, 2021 Has for 24 years been leading product development, Neil brings three decades of valuable experience. He has forged commercialize‐tion, marketing and operations improve

  11. Slide 11: Board of Directors as of November 15, 2021

    Board of Directors as of November 15, 2021 Christopher John Don Michael Jan Peter Lindop McDonough Hardison Singer Leth Christensen Mørch Eriksen CHAIRMAN VICE CHAIRMAN BOARD MEMBER BOARD MEMBER BOARD MEMBER BOARD MEMBER SINCE 2019 SINCE 2021 SINCE 2021 SINCE 2019 SINCE 2021 SINCE 2021 Over 15 years

  12. Slide 12: Regulatory update

    Regulatory update The NGAL Test is CE marked and available for IVD use in the European Union, Canada, S. Korea and Israel. For research use only in all other territories. © Copyright BioPorto 12

  13. Slide 13: Results from interim analysis as expected, but enrollment delayed by COVID-19

    Results from interim analysis as expected, but enrollment delayed by COVID-19 Pediatric study Interim analysis • Number of participating sites in the US clinical trial for The NGAL Test in pediatrics increased to • EARNEST data evaluated 14 during Q3 2021 • Sensitivity, specificity and 1 in 4 affect

  14. Slide 14: US Regulatory Strategy for NGAL

    R E G U L AT O R Y & M A R K E T E X PA N S I O N US Regulatory Strategy for NGAL Pediatric Adult Expansion Areas Breakthrough Designation Predict AKI risk (stage 2/3) Nephrotoxicity: Oncology, Cardi Predict AKI risk (stage 2/3) in the ICU ology, Diabetes, Transplant, Aut in the PICU Urine or plasma

  15. Slide 15: Testing of The NGAL Test for EUA in relation to COVID-19 patients initiated

    Testing of The NGAL Test for EUA in relation to COVID-19 patients initiated • In Q3 2021, BioPorto has progressed dialogue with FDA on a EUA of The NGAL Test in screening COVID-19 patients for risk of renal failure • BioPorto has based on positive dialogue, initiated testing of original samples coll

  16. Slide 16: Rigshospitalet is finalizing interim data report on gRAD-based Sepsis test

    Rigshospitalet is finalizing interim data report on gRAD-based Sepsis test Assay Development Timeline • BioPorto and Rigshospitalet (DK) are co- developing a gRAD test for quantitative determination of thrombomodulin in human plasma Analytical Clinical trial Start patient Clinical testi testing agre

  17. Slide 17: Data collection for gRAD COVID-19 is being evaluated; conclusion expected at year-end 2021

    Data collection for gRAD COVID-19 is being evaluated; conclusion expected at year-end 2021 Nucleocapsid protein (N) • Focus is to secure a sensitivity above 80% to strengthen the platform’s potential • Initial results indicate a higher sensitivity compared to other rapid test formats Spike • Results

  18. Slide 18: 2021 guidance

    2021 guidance © Copyright BioPorto 18

  19. Slide 19: Targeted 2021 Milestones

    Clinical, regulatory and commercial Targeted 2021 Milestones • Continue enrollment of patients for the US FDA application for The NGAL Test in pediatrics • Collect supplementary data to support submission of an application for The NGAL Test in adults • Conclude on interim data for gRAD-based Sepsis

  20. Slide 20: Guidance: Reduced cost strengthens cash position

    Guidance: Reduced cost strengthens cash position end-year and provides cash until Q3 2022 Approx. Approx. Revenue EBIT loss DKK 24m DKK 63m (previously DKK 30m) (previously DKK 73m) Guidance for 2021 is dependent on the global development of COVID-19. Changes to the current outlook for a gradual ope

  21. Slide 21: Financial Calendar 2021

    Financial Calendar 2021 November 17, 2021 Q3 2021 Results Contact: Peter Mørch Eriksen (CEO) investor@bioporto.com © Copyright BioPorto 21

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